Generic drugs for hypertension: are they really equivalent?

Abstract

Many antihypertensive drugs are now available in generic formulations at fractions of the cost of their branded counterparts. In the United States, marketing approval for generic medications is usually granted by the Food and Drug Administration on the basis of two simple studies involving dissolution rates and bioavailability in 24 - 36 healthy people, without data regarding antihypertensive efficacy, safety, or long-term outcomes. This process leaves many true disciples of "Evidence-Based Medicine" in a quandary: prescribe only brand-name medications that have been demonstrated in clinical trials to both lower blood pressure and prevent cardiovascular events, or instead recommend lower-priced generic agents that are usually supported by no such data. This review summarizes the current evidence that generic antihypertensive drugs are likely to be safe and effective, may increase the probability of medication availability and adherence for many patients, but, by law, must have a different physical appearance than the original product.

• Authors: Rhonda M Cooper-DeHoff, William J Elliott
• Journal: Current hypertension reports (Curr Hypertens Rep) Vol. 15 Issue 4 Pg. 340-5 (Aug 2013) ISSN: 1534-3111 [Electronic] United States
• PMID: 23700299 (Publication Type: Journal Article, Review)

Chemical References

• Antihypertensive Agents
• Drugs, Generic

Topics

• Animals
• Antihypertensive Agents (pharmacokinetics, therapeutic use)
• Biological Availability
• Drugs, Generic (pharmacokinetics, therapeutic use)
• Evidence-Based Medicine
• Humans
• Hypertension (drug therapy)
• Treatment Outcome